Software Development Compliance Director

A company is looking for an Associate Director of Software Development Compliance.

Key Responsibilities

Define and maintain a compliant software development lifecycle integrated with quality management system processes

Ensure alignment of software development artifacts with regulatory design controls and objective evidence expectations

Lead verification and validation activities, ensuring compliance with relevant standards and guidelines

Required Qualifications

At least 8+ years of experience in software development compliance in a regulated medical device or diagnostics environment

Deep working knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR 820.30

Proven track record leading requirements engineering and software verification functions

Experience with Class II and III regulatory applications, particularly for IVD software products

Experience collaborating with cross-functional teams, including software developers and quality assurance members